II 

114TH CONGRESS 

1ST SESSION S. 1077 

To provide for expedited development of and priority review for breakthrough 

devices. 

IN THE SENATE OF THE UNITED STATES 

APRIL 23, 2015 

Mr. BURR (for himself, Mr. BENNET, and Mr. HATCH) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To provide for expedited development of and priority review 

for breakthrough devices. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Advancing Break5 through Devices for Patients Act of 2015’’. 

6 SEC. 2. EXPEDITED DEVELOPMENT OF AND PRIORITY RE7 VIEW FOR BREAKTHROUGH DEVICES. 

8 (a) IN GENERAL.—Chapter V of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend10 ed by inserting after section 515A the following: 


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1 ‘‘SEC. 515B. EXPEDITED DEVELOPMENT OF AND PRIORITY 

2 REVIEW FOR BREAKTHROUGH DEVICES. 

3 ‘‘(a) IN GENERAL.—In order to provide for more ef4 fective treatment or diagnosis of life-threatening or irre5 versibly debilitating human disease or conditions, the Sec6 retary shall establish a program to expedite the develop7 ment of and provide for the priority review for devices— 

8 ‘‘(1) representing breakthrough technologies; 

9 ‘‘(2) for which no approved alternatives exist; 

10 ‘‘(3) offering significant advantages over exist11 ing approved or cleared alternatives, including the 

12 potential, compared to existing approved alter13 natives, to reduce or eliminate the need for hos14 pitalization, improve patient quality of life, facilitate 

15 patients’ ability to manage their own care (such as 

16 through self-directed personal assistance), or estab17 lish long-term clinical efficiencies; or 

18 ‘‘(4) the availability of which is in the best in19 terest of patients. 

20 ‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 

21 device may request that the Secretary designate the device 

22 for expedited development and priority review under this 

23 section. Any such request for designation may be made 

24 at any time prior to the submission of an application 

25 under section 515(c), a petition for classification under 

26 section 513(f)(2), or a notification under section 510(k). 


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1 ‘‘(c) DESIGNATION PROCESS.— 

2 ‘‘(1) IN GENERAL.—Not later than 60 calendar 

3 days after the receipt of a request under subsection 

4 (b), the Secretary shall determine whether the device 

5 that is the subject of the request meets the criteria 

6 described in subsection (a). If the Secretary deter7 mines that the device meets the criteria, the Sec8 retary shall designate the device for expedited devel9 opment and priority review. 

10 ‘‘(2) REVIEW.—Review of a request under sub11 section (b) shall be undertaken by a team that is 

12 composed of experienced staff and managers of the 

13 Food and Drug Administration and is chaired by a 

14 senior manager. 

15 ‘‘(3) WITHDRAWAL.—The Secretary may not 

16 withdraw a designation granted under this section 

17 on the basis of the criteria under subsection (a) no 

18 longer applying because of the subsequent clearance 

19 or approval of another device that— 

20 ‘‘(A) was designated under this section; or 

21 ‘‘(B) was given priority review under sec22 tion 515(d)(5), as in effect prior to the date of 

23 enactment of the Advancing Breakthrough De24 vices for Patients Act of 2015. 


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1 ‘‘(d) EXPEDITED DEVELOPMENT AND PRIORITY RE2 VIEW.— 

3 ‘‘(1) ACTIONS.—For purposes of expediting the 

4 development and review of devices designated under 

5 subsection (c) the Secretary shall— 

6 ‘‘(A) assign a team of staff, including a 

7 team leader with appropriate subject matter ex8 pertise and experience, for each device for 

9 which a request is submitted under subsection 

10 (b); 

11 ‘‘(B) provide for oversight of the team by 

12 senior agency personnel to facilitate the effi13 cient development of the device and the efficient 

14 review of any submission described in sub15 section (b) for the device; 

16 ‘‘(C) adopt an efficient process for timely 

17 dispute resolution; 

18 ‘‘(D) provide for interactive and timely 

19 communication with the sponsor of the device 

20 during the development program and review 

21 process; 

22 ‘‘(E) expedite the Secretary’s review of 

23 manufacturing and quality systems compliance, 

24 as applicable; 


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1 ‘‘(F) disclose to the sponsor not less than 

2 5 business days in advance the topics of any 

3 consultation the Secretary intends to undertake 

4 with external experts or an advisory committee 

5 concerning the sponsor’s device and provide the 

6 sponsor the opportunity to recommend such ex7 ternal experts; 

8 ‘‘(G) provide for advisory committee input, 

9 as the Secretary determines appropriate (in10 cluding in response to the request of the spon11 sor) for applications submitted under section 

12 515(c); and 

13 ‘‘(H) assign staff to be available within a 

14 reasonable time to address questions by institu15 tional review committees concerning the condi16 tions and clinical testing requirements applica17 ble to the investigational use of the device pur18 suant to an exemption under section 520(g). 

19 ‘‘(2) ADDITIONAL ACTIONS.—In addition to the 

20 actions described in paragraph (1), for purposes of 

21 expediting the development and review of devices 

22 designated under subsection (c), the Secretary, in 

23 collaboration with the device sponsor, may, as appro24 priate— 


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1 ‘‘(A) coordinate with the sponsor regarding 

2 early agreement on a data development plan; 

3 ‘‘(B) take steps to ensure that the design 

4 of clinical trials is as efficient as practicable, 

5 when scientifically appropriate, such as through 

6 adoption of shorter or smaller clinical trials, ap7 plication of surrogate endpoints, and the use of 

8 adaptive trial designs and Bayesian statistics, 

9 to the extent scientifically appropriate; 

10 ‘‘(C) facilitate, when scientifically appro11 priate, expedited and efficient development and 

12 review of the device through utilization of time13 ly post-market data collection with regard to 

14 application for approval under section 515(c); 

15 and 

16 ‘‘(D) agree in writing to clinical protocols 

17 that the Secretary will consider binding on the 

18 Secretary and the sponsor, subject to— 

19 ‘‘(i) changes to such protocols agreed 

20 to in writing by the sponsor and the Sec21 retary; or 

22 ‘‘(ii) a decision, made by the director 

23 of the office responsible for reviewing the 

24 device submission, that a substantial sci25 entific issue essential to determining the 


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1 safety or effectiveness of such device exists, 

2 provided that such decision is in writing, 

3 and is made only after the Secretary pro4 vides to the device sponsor or applicant an 

5 opportunity for a meeting at which the di6 rector and the sponsor or applicant are 

7 present and at which the director docu8 ments the substantial scientific issue. 

9 ‘‘(e) PRIORITY REVIEW GUIDANCE.— 

10 ‘‘(1) CONTENT.—Not later than 1 year after 

11 the date of enactment of the Advancing Break12 through Devices for Patients Act of 2015, the Sec13 retary shall issue guidance on the implementation of 

14 this section. Such guidance shall— 

15 ‘‘(A) set forth the process by which a per16 son may seek a designation under subsection 

17 (c); 

18 ‘‘(B) provide a template for requests under 

19 subsection (b); 

20 ‘‘(C) identify the criteria the Secretary will 

21 use in evaluating a request for designation 

22 under this section; and 

23 ‘‘(D) identify the standards the Secretary 

24 will use in assigning a team of staff, including 

25 team leaders, to review devices designated for 


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1 expedited development and priority review, in2 cluding any training required for such per3 sonnel to ensure effective and efficient review. 

4 ‘‘(2) PROCESS.—Prior to finalizing the guid5 ance under paragraph (1), the Secretary shall seek 

6 public comment on a proposed guidance. 

7 ‘‘(f) CONSTRUCTION.— 

8 ‘‘(1) PURPOSE.—This section is intended to en9 courage the Secretary and provide the Secretary suf10 ficient authorities to apply efficient and flexible ap11 proaches to expedite the development of, and 

12 prioritize the Food and Drug Administration’s re13 view of, devices that represent breakthrough devices. 

14 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

15 this section shall be construed to affect— 

16 ‘‘(A) the criteria and standards for evalu17 ating an application pursuant to section 515(c), 

18 a report and request for classification under 

19 section 513(f)(2), or a report under section 

20 510(k), including the recognition of valid sci21 entific evidence as described in section 

22 513(a)(3)(B) and consideration and application 

23 of the least burdensome means of evaluating de24 vice effectiveness or demonstrating substantial 


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1 equivalence between devices with differing tech2 nological characteristics, as applicable; 

3 ‘‘(B) the authority of the Secretary with 

4 respect to clinical holds under section 

5 520(g)(8)(A); or 

6 ‘‘(C) the authority of the Secretary to act 

7 on an application pursuant to section 515(d) 

8 before completion of an establishment inspec9 tion, as the Secretary determines appropriate.’’. 

10 (b) DOCUMENTATION AND REVIEW OF SIGNIFICANT

11 DECISIONS.—Section 517A(a)(1) of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is 

13 amended by inserting ‘‘a request for designation under 

14 section 515B,’’ after ‘‘application under section 515,’’. 

15 (c) TERMINATION OF PREVIOUS PROGRAM.— 

16 (1) IN GENERAL.—Section 515(d) of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

18 360e(d)) is amended— 

19 (A) by striking paragraph (5); and 

20 (B) by redesignating paragraph (6) as 

21 paragraph (5). 

22 (2) CONFORMING AMENDMENT.—Section 

23 737(5) of the Federal Food, Drug, and Cosmetics 


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1 Act (21 U.S.C. 379i(5)) is amended by striking 

2 ‘‘515(d)(6)’’ and inserting ‘‘515(d)(5)’’. 

Æ 


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